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Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib

S

Sohag University

Status

Not yet enrolling

Conditions

Rheumatoid Arthritis

Treatments

Device: Nerve Conduction Study

Study type

Interventional

Funder types

Other

Identifiers

NCT06977035
Soh--Med--25-4-09MS

Details and patient eligibility

About

Rheumatoid arthritis is a chronic, systemic, autoimmune inflammatory disease that mainly affects the joints and periarticular soft tissues. Baricitinib (Olumiant®) is an oral, targeted synthetic DMARD that inhibits JAK1 and JAK2, which are implicated in the pathogenesis of rheumatoid arthritis (RA). Nerve conduction studies (NCSs) are an essential tool in the evaluation of the peripheral nervous system. The sensory nerve action potential (SNAP) provides information on the sensory nerve axon and its pathway from the distal receptors in the skin to the dorsal root ganglia, while the compound muscle action potential (CMAP) is an assessment of the motor nerve fibers from their origins in the anterior horn cell to their termination along muscle fibers.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients fulfill the 2010 ACR/EULAR classification criteria of RA
  2. Age above 18 years old.
  3. Patient cooperative and can answer questions

Exclusion criteria

  1. Other rheumatologic or collagen diseases.
  2. Age below 18 years and above 65 years.
  3. Uncooperative patients.
  4. Patients with other causes of peripheral neuropathy as Diabetes mellitus.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Rheumatoid Arthritis patients on Baricitinib treatment
Active Comparator group
Treatment:
Device: Nerve Conduction Study
Rheumatoid Arthritis patient on conventional synthetic DMARD
Active Comparator group
Treatment:
Device: Nerve Conduction Study

Trial contacts and locations

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Central trial contact

Ahmed R Alagamy, Associate Professor; Sara K Mohamed, Resident

Data sourced from clinicaltrials.gov

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